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- Supports execution of External Regulations Standards and Guidance Documents packages through tracking and monitoring ePAS packages from draft to final closure
- Prepares metrics associated with the process for Executive Management Review (EMR) * Completes final signature approval of an ePAS package (i.e., FSG Approval)
- Data review, analysis, and verification.
- Strong analytical and problem-solving skills.
- Demonstrated competency and working knowledge of Excel, Word, PowerPoint, SharePoint, and Teams.
- Communicate effectively verbally and in writing. Communicate with diverse audiences and personnel. Write and edit technical documents.
- Ability to work with people from various disciplines and cultures.
- Strong attention to detail.
- Good organizational / project management skills to manage and track a wide range of tasks; ability to develop realistic action plans as well as prioritizing work activities.
- Similar skillset with a more regulatory or quality experience would be beneficial.
- BS in engineering or scientific degree / 1+ years experience in a medical device or similarly regulated industry.
Regulatory Affairs Associate Jr - Lake Forest, United States - Spectraforce Technologies
Description
Job Title: Regulatory Affairs Associate JrDuration: 7 months
Location: Lake Forest, IL 60045
Responsibilities: